Application 203978
- Type
- ANDA
- Sponsor
- INFORLIFE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | 20MG/200ML (0.1MG/ML) | No | No |
| 002 | NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | 40MG/200ML (0.2MG/ML) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78587 | ORIG | 2024-05-31 |